Flibanserin: Restoring Female Sexual Desire and Satisfaction
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Synonyms | |||
Flibanserin is a non-hormonal, centrally-acting medication approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It represents a significant advancement in addressing the neurobiological underpinnings of low libido, offering a targeted approach that differs from previous symptomatic or hormonal interventions. By modulating key neurotransmitters in the brain, it helps restore balance to the neural circuits responsible for sexual interest, providing a clinically validated option for women experiencing this distressing condition.
Features
- Active ingredient: Flibanserin 100 mg
- Pharmacological class: Multifunctional serotonin receptor agonist and antagonist
- Administration: Oral tablet, once daily at bedtime
- Prescription status: Schedule-controlled substance requiring healthcare provider consultation
- Mechanism: Acts on serotonin (5-HT1A agonist/5-HT2A antagonist) and dopamine receptors in prefrontal cortex
- Bioavailability: Approximately 33% following oral administration
- Half-life: Approximately 11 hours
- Metabolism: Primarily hepatic via CYP3A4 and secondarily via CYP2C19
Benefits
- Increases spontaneous and responsive sexual desire through central nervous system modulation
- Reduces sexually-related personal distress and improves sexual satisfaction scores
- Enhances overall sexual function, including frequency of satisfying sexual events
- Improves emotional well-being and relationship satisfaction
- Provides non-hormonal alternative for premenopausal women with HSDD
- Demonstrated efficacy in multiple randomized controlled clinical trials
Common use
Flibanserin is specifically indicated for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women. HSDD is characterized by persistent or recurrent deficiency of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, which is not better accounted for by another medical condition, substance use, or severe relationship distress. The condition must be acquired (developing in a patient who previously had no problems with sexual desire) and generalized (not situational). Clinical studies have demonstrated effectiveness in diverse populations of premenopausal women meeting these diagnostic criteria.
Dosage and direction
The recommended dosage is 100 mg taken orally once daily at bedtime. Administration at bedtime is crucial to minimize the risk of hypotension, syncope, and central nervous system depression. The tablet should be swallowed whole with water and not crushed or divided. Dose adjustment is not recommended based on age, race, or mild hepatic impairment. For patients with moderate hepatic impairment, the recommended dose is 50 mg once daily at bedtime. Flibanserin is contraindicated in patients with severe hepatic impairment. Treatment discontinuation should be considered after 8 weeks if no improvement in sexual desire and associated distress is observed.
Precautions
Patients should be advised about the risk of hypotension and syncope, particularly in the context of alcohol consumption. Concomitant use with moderate or strong CYP3A4 inhibitors is contraindicated. Caution is advised when using with CNS depressants, including benzodiazepines, narcotics, and sleep aids. Hepatic function should be assessed prior to initiation and periodically during treatment. Patients should be monitored for somnolence, sedation, and fatigue. Use with caution in patients with low blood pressure or those taking antihypertensive medications. Women should use effective contraception during treatment as safety during pregnancy has not been established.
Contraindications
Concomitant use with alcohol is absolutely contraindicated due to increased risk of severe hypotension and syncope. Concomitant use with moderate or strong CYP3A4 inhibitors including ketoconazole, itraconazole, clarithromycin, ritonavir, and grapefruit juice is contraindicated. Patients with hepatic impairment classified as Child-Pugh B (moderate) or C (severe) should not use flibanserin except with dose adjustment as specified for moderate impairment. History of hypersensitivity to flibanserin or any component of the formulation prohibits use. Concomitant use with other central nervous system depressants requires careful risk-benefit assessment.
Possible side effects
The most common adverse reactions (≥2%) include dizziness (11.4%), somnolence (11.2%), nausea (8.3%), fatigue (7.7%), insomnia (4.9%), dry mouth (3.5%), and flushing (2.4%). Syncope was reported in 0.4% of patients at the 100 mg dose. Less common side effects include anxiety, constipation, abdominal pain, and paresthesia. Most adverse reactions are mild to moderate in severity and often diminish with continued treatment. Patients should be advised not to drive or engage in potentially hazardous activities until they know how flibanserin affects them.
Drug interaction
Flibanserin is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19. Concomitant use with strong CYP3A4 inhibitors increases flibanserin exposure approximately 7.5-fold. Moderate CYP3A4 inhibitors increase exposure approximately 3.5-fold. Concomitant use with CYP2C19 inhibitors may increase flibanserin exposure. Flibanserin may increase concentrations of drugs that are CYP2C9 substrates. Additive effects on blood pressure and CNS depression may occur with antihypertensives, alpha-blockers, and CNS depressants. The interaction with alcohol is particularly dangerous, causing profound hypotension and syncope.
Missed dose
If a dose is missed, patients should skip the missed dose and take the next dose at the regular time the following bedtime. Patients should not take two doses at the same time to make up for a missed dose. Doubling the dose significantly increases the risk of adverse effects including severe hypotension, syncope, and CNS depression. If multiple doses are missed, patients should consult their healthcare provider before resuming treatment to determine if dose adjustment or additional monitoring is necessary.
Overdose
In case of suspected overdose, immediate medical attention should be sought. Symptoms may include severe hypotension, syncope, CNS depression, and profound sedation. There is no specific antidote for flibanserin overdose. Treatment should consist of supportive measures including continuous hemodynamic monitoring, intravenous fluids, and vasopressors if needed for hypotension. Gastric lavage or activated charcoal may be considered if ingestion was recent. Patients should be monitored for at least 24 hours due to the drug’s half-life of approximately 11 hours.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture and light. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Properly discard any unused medication through medication take-back programs or according to FDA-recommended disposal guidelines. Do not flush medications down the toilet or pour down the drain unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Flibanserin is available by prescription only and should be used under the supervision of a qualified healthcare provider. Individual results may vary. Patients should discuss their medical history, current medications, and treatment goals with their healthcare provider before starting treatment. The full prescribing information including boxed warning about alcohol interaction should be reviewed before initiation. This medication is not indicated for use in postmenopausal women or men.
Reviews
Clinical trial data demonstrate that approximately 48-53% of women treated with flibanserin 100 mg experienced meaningful improvement in sexual desire compared to 28-34% with placebo. Patients reported increased sexually satisfying events (0.8-1.0 additional events per month over placebo) and reduced distress related to sexual desire. Real-world evidence suggests similar efficacy patterns with proper patient selection and adherence to administration guidelines. Patient-reported outcomes indicate improvements in relationship satisfaction and overall quality of life. The majority of adverse effects were reported as mild to moderate and often transient in nature.